Kornimate/medical-research-clean huggingface dataset:
a phase i/ii study of bgt226 in adult patients with advanced solid malignancies including patients with advanced breast cancer

Conditions: Solid Tumors; Breast Cancer; Cowden Syndrome

Summary: this is a phase i/ii clinical research study with bgt226, an inhibitor of phosphatidylinositol 3'-kinase (pi3k). the study consists of a phase i dose escalation part followed by a safety expansion part and a phase ii expansion part. once the mtd has been defined, the safety expansion and efficacy expansion parts of the trial will be opened for enrollment. phase i safety expansion part will enroll advanced solid tumors. phase ii expansion part will enroll advanced breast cancer. an effort will be made to enrich the trial population with cowden syndrome patients with advanced solid malignancies.


Eligibility criteria:
inclusion criteria: all patients * histologically-confirmed, advanced solid tumors * progressive, recurrent unresectable disease phase ii expansion part (advanced breast cancer) * confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive her-2 expression status * disease progression/recurrence following hormonal or anti-her-2 treatment for advanced disease * at least one but not more than two prior chemotherapy regimens for the unresectable tumor * measurable disease by mri or ct scan cowden syndrome patients with an advanced malignancy genetic confirmation of cowden syndrome * age ≥ 18 * world health organization (who) performance status of ≤ 2 exclusion criteria: * hematopoietic: * no diabetes mellitus or history of gestational diabetes mellitus * no acute or chronic renal disease * no acute or chronic liver disease * no acute or chronic pancreatitis * no impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension * no acute myocardial infarction or unstable angina pectoris within the past 3 months * not pregnant or nursing and fertile patients must use barrier contraceptives other protocol-defined inclusion/exclusion criteria may apply.

Keywords: bgt226 solid tumors breast cancer cowden syndrome phosphatidylinositol 3'-kinase (pi3k) inhibitor advanced solid tumors (including sporadic and cowden syndrome) (phase i part) advanced breast cancer (including sporadic and cowden syndrome) (phase ii part)
cervical radiculopathy imaging using mrn with electrodiagnostic correlation

Conditions: Cervical Radiculopathy

Summary: this project will study patients with cervical radiculopathy. we will evaluate the combined diagnostic and prognostic value of magnetic resonance neurography (mrn), electrodiagnostic (edx) studies, and historical and physical clinical elements. specifically, this project will explore whether these data individually or in combination correlate with response to procedural and non-procedural treatment.


Eligibility criteria:
inclusion criteria: * patients presenting with symptoms compatible with acute or subacute unilateral (one-sided) cervical radiculopathy and signs of clinical weakness * 18-60 years old at the time of evaluation * symptom onset of 2 to 12 weeks leading up to baseline visit * diagnosis of unilateral cervical radiculopathy, with or without spinal cord compression, based on signs and symptoms, physical exam and supported by mri findings of radiculopathy (as evidenced by foraminal stenosis/narrowing) based on standard-of-care cervical spine mri * patients who have undergone or have planned electrodiagnostic testing at hss prior to surgery exclusion criteria: * prior cervical surgery or instrumentation * those who have had a prior episode of cervical radiculopathy * history of peripheral neuropathy or another acute or chronic neurodegenerative condition * history of stroke, cerebellar disease, or central nervous system disease * contraindications to undergoing a standard mri examination (e.g., pregnancy) * patients presenting with bilateral cervical radiculopathy
retrospective study to describe prevalence of hyperkalemia in russian population based on large laboratory network (hekate)

Conditions: Hyperkalemia Elevated Plasma K+ Cardiovascular Disease (CVD)

Summary: this is a cross-sectional retrospective study of laboratory records of patients who take electrolytes blood tests containing the data of the serum potassium level. this study is an observational one, and there is no intervention into routine clinical practice either in terms of therapy, or special examinations.


Eligibility criteria:
inclusion criteria: * males and females tested in the russian centres of invitro laboratory from 01.01.2015 till 31.12.2016; * 18 years and older; * available electrolytes blood test containing of the serum potassium level of the unique patient fits for interpretation. exclusion criteria: * blood test cannot be interpreted due to various reasons. * blood samples with sing of hemolysis
pet imaging targeting granzyme b predicts immunotherapy efficacy in diffuse large b-cell lymphoma

Conditions: Diffuse Large B-Cell Lymphoma

Summary: this study aims to investigate the predictive value of pet imaging targeting granzyme b on the outcome of patients with diffuse large b lymphoma receiving immunotherapy.

the investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. all participants will undergo 68ga-grazytracer pet at baseline and after one course of immunotherapy (car-t, glofitamab or ir2 ).

Eligibility criteria:
inclusion criteria: 1. pathologic diagnosis of dlbcl 2. patient's general condition is good and survival is expected to be greater than six months 3. signed and dated informed consent form exclusion criteria: 1. combined with other malignant tumors 2. patients with serious medical conditions who, in the opinion of the investigator, are not suitable for participation in this clinical study 3. pregnant women and women at risk of pregnancy, breastfeeding women 4. poor compliant

Keywords: pet/ct granzyme b immunotherapy
renal regional oxygen saturation during transcatheter aortic valve implantation

Conditions: Kidney Injury, Acute; Transcatheter Aortic Valve Implantation

Summary: this prospective observational study evaluates the association of peri-procedural changes in renal regional oxygen saturation and post-procedural acute kidney injury in patients undergoing transcatheter aortic valve implantation.

this prospective observational cohort study evaluated the association of renal regional oxygen saturation, measured during transcatheter aortic valve implantation, and post-procedural acute kidney injury. renal regional oxygen saturation is measured using near-infrared spectroscopy on the skin surface over the kidneys.

Eligibility criteria:
inclusion criteria: * adult patients (\>= 20 years old) undergoing transcatheter (transfemoral) aortic valve implantation exclusion criteria: * emergent procedure * pre-procedural severe renal impairment (egfr \< 30 ml/min/1.73 m2) * pre-procedural hemodialysis * distance from skin to renal capsule \> 4 cm * pre-procedural mechanical ventilation * refuse to participate

Keywords: renal regional oxygen saturation acute kidney injury transcatheter aortic valve implantation
screening study for participants with malignant tumors

Conditions: Solid Tumors

Summary: the study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked roche clinical trial.


Eligibility criteria:
general inclusion criteria: * confirmed availability of a representative formalin-fixed, paraffin-embedded (ffpe) tumor specimen meeting criteria defined in the protocol * considered by principal investigator (pi) to be a candidate for a linked clinical trial with an investigational medicinal product, and that the participant has the awareness and willingness to participate in said trial inclusion criteria for participants with stage iii nsclc * locally advanced, unresectable stage iii nsclc of either squamous or non-squamous histology based on 8th edition of the american joint committee on cancer (ajcc) and union for international cancer control (uicc) cancer staging system * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 inclusion criteria for participants with stage ii, iiia, or select iiib (t3n2 only) nsclc requiring adjuvant treatment * stage ii, iiia, or select iiib (t3n2 only) nsclc based on the 8th edition of the ajcc and uicc cancer staging system (amin et al. 2017) * considered eligible for curative intent surgery (complete resection with all surgical margins testing negative for tumor) * screening within study bx43361, using a pretreatment biopsy, is encouraged to be performed as early in the participant treatment pathway as possible to ensure the participant is potentially eligible for all cohorts, and should meet guidelines as defined by the protocol * representative ffpe tumor specimen obtained prior to the start of any treatment * ecog performance status of 0 or 1 general exclusion criteria: * history of malignancy other than nsclc within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death * any condition that may affect the interpretation of study results * significant liver or cardiovascular disease * prior allogenic stem-cell or solid-organ transplantation
the sculpt-job cohort study

Conditions: Weight Maintenance; Weight Loss; Stress, Psychological; Job Stress; Diabetes Prevention; Obesity; Cardiovascular Risk Factor; Cardiovascular Diseases

Summary: this is an research study about clinical, psychosocial, and behavioral factors that impact weight loss, weight maintenance, and cardiovascular disease in socially disadvantaged persons.

this study aims to evaluate the impact of the diabetes prevention program (dpp) at 12 months among socioeconomically diverse participants by examining: changes in body mass index (bmi); improvements in ideal cardiovascular health scores (based on aha 2020 goals and life's essential 8, where sleep data is available); and reductions in psychosocial stress.

Eligibility criteria:
inclusion criteria: •. inlcudes participants from socioeconomically diverse backgrounds, age \> 18 years old, and bmi \> 25 kg/m2 (for asian ethnicity bmi\> 22 kg/m2). exclusion criteria will include pregnancy or post-partum state (\< 12 months post-partum), history of diabetes (type 1 or 2), history of myocardial infarction, stroke or cardiac arrest in the prior 2 years, history of physician diagnosed cognitive, developmental or psychiatric conditions, recent orthopedic diagnosis or surgery (\< 6 months) , inability to speak english, spanish, or chinese, persons facing housing eviction or undergoing an active housing leasing process (e.g getting their credit report in shape for a potential lease, in the process of getting a new housing lease).
a study in critically ill patients investigating tolerability and efficacy of low-volume pharmaconutrition (intestamin)

Conditions: Critical Illness; Adult; Sepsis; Systemic Inflammatory Response Syndrome

Summary: the aim of the study is to assess the efficacy and tolerability of the low-volume supplement. the investigators randomized critically ill patients to receive intestamin plus fresubin or fresubin alone.

to compare early supplementation with antioxidants and glutamine using an enteral pharmaconutrition supplement (intestamin®) to an energy adjusted standard elementary diet and to investigate its affect on clinical efficacy and tolerability in critically ill patients with sepsis/sirs. methods: this was a prospective controlled randomized study in 58 critically ill patients. they received either intestamin or a diluted fresubin solution. after 10 or 14 days inflammatory parameters, catecholamine need, and maximal enteral delivery were determined.

Eligibility criteria:
inclusion criteria: * sepsis or sirs (apache score 10-30), * no severe gastrointestinal tract or metabolic diseases, * enteral feeding within 48 h of admission, * age 18-75 years, * written consent by patient or next of kin. - exclusion criteria: * participation in a drug trial within the last 4 weeks before inclusion in this study, * previous participation in this study, * expected patient survival of less than 6 days, * pregnancy or lactation, * patients with unstable vital signs that would probably cause incidents that would make participation impossible or would lead to discontinuation, * severe liver disease with cytolysis (asat \>10 n) or impaired detoxification (ammonia \>50 mmol/l, bilirubin \> 50 μmol/l), * gastrointestinal surgery in the last 4 weeks, * severe enteritis/colitis, * short intestine syndrome, * gastrointestinal bleeding that requires intervention, * patients who could not be enterally fed

Keywords: critically ill sepsis antioxidants enteral nutrition sirs (apache score 10-30) enteral feeding within 48 h of admission
novasight hybrid intravascular ultrasound and optical coherence tomography system (ivus oct)

Conditions: Stable Angina; Acute Coronary Syndrome

Summary: collection of coronary images with a hybrid ivus oct system.

a prospective observational imaging study in patients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for pci following a presentation with either stable angina or an acute coronary syndrome.

Eligibility criteria:
inclusion criteria: 1. patient is at least 18 years old. 2. patients arriving for coronary angiography or possible pci with stable angina or acute coronary syndrome (including unstable angina, nstemi or stemi). 3. patients with stemi may be undergoing subsequent staged pci to additional coronary stenoses after the index stemi event has been successful treated with primary pci. 4. vascular access of at least 6f. 5. patient provides informed, written consent for participation in the study. 6. a target lesion is present in a suitable artery for intravascular imaging. exclusion criteria: 1. angiographic evidence of severe calcification 2. marked tortuosity that precludes imaging of a target coronary artery. 3. gfr (glomerular filtration rate) \<35 ml/min. 4. patients in cardiogenic shock. 5. women of child bearing potential, in whom pregnancy cannot be excluded. 6. patients of age \< 18 years old. 7. patients with an allergy to contrast. 8. patients unable to grant informed, written consent for participation in the study.
fever during labour

Conditions: Fever; Due to Heat; Infection

Summary: pilot study to assess fever during labour.

200 parturients will be monitored for fever during labour using rectal thermometer. repeated measurements 1/hr during the first 6 hours will allow us to find patients developing fever. fever = rectal temp \>38 celsius twice within 60 min or 39 degrees celsius measured once . after birth, blood samples are assessed for infection. use of antibiotics and other medication is recorded. subgroup analyses based on suspected causes of fever during birth.

Eligibility criteria:
inclusion criteria: * age \> 18 years, planned vaginal birth, able to give consent exclusion criteria: * do not speak danish or english, unable to cooperate to rectal temperature measurements,

Keywords: fever epidural birth labour
trisomy 21 in adulthood

Conditions: Down Syndrome

Summary: trisomy 21 or down syndrome, is the most common genetic cause of cognitive disability. currently, in alsace, the birth prevalence is about 1 in 1600 live births, which means 10 liveborns with down syndrome each year.if screening and prenatal diagnosis of children with trisomy 21, as well as medical care, social and educational integration in childhood was the subject of much research and has led to remarkable progress in terms of health and medical care, it is not the same for the knowledge about adolescents and adults.despite a more and more higher life expectancy, the evolution of trisomy 21 in adulthood is often marked by a deterioration in health status, with a regression of acquired psychomotor skills, often attributed only to the precocious occurrence of alzheimer's dementia. nevertheless, it seems that the diagnosis of alzheimer's dementia is often overdiagnosed, and it is well established that only a fraction of down syndrome patients will develop this type of dementia. too often a decline in general health, behavioral changes and decreased cognitive abilities are only attributed to the down syndrome with an early dementia without looking for an underlying, potentially curable, disease.this study aims to better evaluate the health and social status of 100 adults with trisomy 21 in alsace. the medical evaluation will include a comprehensive assessment of health status and quality of life conducted by the geneticist, a cardiac, sensory, hormonal, biological and radiological evaluation. a speech-language and psychomotor evaluation will also be conducted. a psychiatric consultation and a psychometric assessment will aim to assess cognitive function and to search for associated mood disorders.the expected results are to better know the natural history of trisomy 21 in adulthood, with the determination of the frequency of morbid events specific to adulthood, and also to improve the medical and paramedical care with the establishment of a monitoring program to prevent the occurrence of these morbid events.


Eligibility criteria:
inclusion criteria: * man or woman older than 18 years * down syndrome (clinical diagnosis, eventually confirmed by blood karyotype) exclusion criteria: * children * pregnancy

Keywords: down syndrome
amplitude modulated radiofrequency electromagnetic field treatment combined with radiochemotherapy and maintenance chemotherapy in patients with glioblastoma (brain-rf)

Conditions: Glioblastoma

Summary: combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

charité universitätsmedizin berlin is currently the only german university hospital with an available capacitive radiofrequency electromagnetic field treatment device. while there is retrospective data available regarding the assumed effectiveness and low toxicity profile of radiofrequency electromagnetic field treatment for glioblastoma in the palliative setting, there is only few prospective data available on the combined effect first-line chemoradiation and radiofrequency electromagnetic field treatment. the investigators aim to conduct a feasibility trial and plan to compare the results with data of a prospective trial with a comparable patient population.

Eligibility criteria:
inclusion criteria: * pathological evidence of newly diagnosed glioblastoma according to who classification criteria * patients 18 to 70 years of age with a who performance status of 2 or less * all patients must sign written informed consent * adequate hematologic, renal, and hepatic function (absolute neutrophil count, ≥1,5 x 103/μl; platelet count, ≥100 x 103/μl; serum creatinine ≤1.7 mg/dl; total bilirubin \> upper limit of normal; ast or alt ≤3 times the upper limit of normal) * patient must have received subtotal or gross total resection of the tumor * mgmt-promotor methylated patients must have refused therapy according to the ceteg/noa-09 protocol (+ lomustin) * patient must be planned for concomitant rct with a total rt dose of 60 gy over six weeks and temozolomide followed by six cycles of maintenance ct using temozolomide exclusion criteria: * previous cranial rt * cytostatic therapy / anti-angiogenic substances / ct or radiation therapy for cancer within the past 5 years * history of cancers or other comorbidities that limit life expectancy to less than five years * postoperative evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness) * technical impossibility to use magnetic resonance imaging (mri) or known allergies against mri and/or computed tomography (ct) contrast agents * technical impossibility to use am-rf-emf (pacemaker, defibrillator or deep brain stimulator, metal implants) * participants of childbearing age unwilling to use or not capable of using effective contraception * pregnant patients
impact of physiotherapy and botox in improving functional outcomes among post stroke focal dystonia patients

Conditions: Focal Hand Dystonia

Summary: this study was conducted to assess the combine role of physiotherapy by providing task specific trainings and botulinum toxin type a in improving the functional outcomes of upper limb in post stroke patients with focal hand dystonia.

post-stroke hemiparesis, with dystonia, is a major cause of disability. dystonia can hinder the functional activities making patient dependent on others for performance of daily living activities. dystonia not only limits the physical activity of the patient but also affects their quality of life significantly. various treatment protocols have been used in the literature for treatment of focal hand dystonia in the past including deep brain stimulation, kinesio taping, sensory oriented training, splinting, extracorporeal shock wave therapy and botox. out of these botox has gained much importance but it results only in improving the passive range of motion and has no consensus in improving the active range of motion and functional independence of the patient. the current study was planned to determine the effects of botulinum toxin type a combined with task-specific therapy, for post-stroke focal dystonia of upper limb.

Eligibility criteria:
inclusion criteria: * patients having first episode of unilateral stroke * at least 6 months of post stroke duration presenting with post stroke focal dystonia of the upper limb. * no previous exposure of the affected hand of botox. * reduced upper limb functions * both genders will be included equally. exclusion criteria: * significant speech or cognitive impairment which impedes the ability to perform the assessment. * other significant upper limb impairment e.g. fracture or frozen shoulder within 6 months. * severe arthritis, amputation, evidence of fixed contracture, pregnancy or lactating womens. * other diagnosis likely to interfere with rehabilitation or outcome assessments, e.g. blind, malignancy, * other conditions which may contribute to upper limb spasticity, e.g. multiple sclerosis, cerebral palsy. * use of botulinum toxin to the upper limb in the previous 4 months. * contraindications to intramuscular injection. * contraindications /allergy to botulinum toxin type a, which include bleeding disorders, myasthenia gravis and concurrent use of aminoglycosides.

Keywords: dystonia task-specific training botulinum toxin type a